Laboratories are deploying artificial intelligence tools to scan digital pathology slides and filter out inadequate tissue specimens before molecular testing begins, tackling a failure rate that affects up to 20% of clinical oncology cases, according to reports.
In Plain English: The Clinical Takeaway
- What’s changing: Pathology labs are using AI to check tissue samples for sufficient tumor content before genetic testing runs.
- What’s next: Tools like Aignostics’ HETA Clinical are speeding up workflows, though they currently remain restricted to research use.
Reducing Specimen Failures in Molecular Pathology
Pathologists estimate that 10% to 20% of molecular diagnostics fail due to a lack of sufficient tumor cells within the collected tissue. This shortfall forces patients to undergo repeat biopsies, delaying diagnosis and treatment planning.
To address this bottleneck, Aignostics launched its HETA Clinical product line. The tools analyze digital pathology slides to assess tissue quality and measure tumor content ahead of molecular assays.
“HETA Clinical allows laboratories to process newly arrived cases much faster,” said Rosemarie Krupar, vice president of pathology at Aignostics. The AI provides stable measurements for tumor cellularity and mitotic counts, allowing pathologists to focus on complex manual evaluations.
Infrastructure Expansion and Regulatory Frameworks
The underlying HETA platform, previously known as Atlas H&E-TME, matches or exceeds human pathology baselines in cell classification across multiple tumor types. Despite these benchmarks, the HETA Clinical product line is currently classified as Research Use Only (RUO) and cannot be used for clinical diagnostics.
At the same time, cancer genetics firm NeoGenomics expanded its partnership with Indica Labs to integrate the HALO AP platform. Steven Hashagen, chief executive officer of Indica Labs, noted that the collaboration pairs NeoGenomics’ precision medicine expertise with digital pathology infrastructure to handle growing volumes of biomarker tests.
| Platform / Tool | Technology Provider | Regulatory Status | Core Function |
|---|---|---|---|
| HETA Clinical | Aignostics | Research Use Only (RUO) | Assesses tumor content and tissue quality to reduce molecular test failure rates. |
| HALO AP | Indica Labs | CE-IVDR (Europe, UK, Switzerland); RUO (US) | Provides digital pathology infrastructure for AI-driven diagnostic development. |
While the HALO AP platform holds the CE-IVDR mark for in vitro diagnostic use in Europe, the United Kingdom, and Switzerland, its deployment in the United States remains restricted to research. Meanwhile, regulatory bodies are establishing controlled environments to test these technologies safely.
In Utah, state regulators created a sandbox mechanism requiring independent external evaluation for any artificial intelligence tool before deployment.
Contraindications & When to Consult a Doctor
Patients undergoing cancer staging, biopsy procedures, or molecular profiling should consult their attending oncologists or pathologists regarding specific test turnaround times and the diagnostic validity of their tissue samples.
References
- Aignostics.
- Indica Labs.
